Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy

Last updated: September 17, 2016
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02360761
CTONG1504
  • Ages > 70
  • All Genders

Study Summary

The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 70 years or older

  • Preoperative criteria (contrast-enhanced Computed tomography scan)

  • Suspected non-small cell lung cancer

  • Clinical stage ⅠA, i.e. T1N0M0 (tumor diameter ≤3 cm, surrounded by visceralpleura, short-axis of lymph node <1 cm or cold lymph nodes on PET scan)

  • The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions

  • Eligible for sublobar resection with sufficient margin

  • Intraoperative criteria

  • Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasiveadenocarcinomas defined by The International Association for the Study of LungCancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)

  • Pathological exclusion of suspected lymph nodes involvement

  • Feasible to perform sublobar resection in terms of surgical margin requirement

  • General criteria

  • Must sign informed consent by the patient or his/her entrusted party

  • Must complete 4-year mortality index and comprehensive geriatric assessment(CGA)if necessary

  • The physiological reservation can tolerate lobectomy

Exclusion

Exclusion Criteria:

  • Unable to comply with the study procedure

  • Past thoracic surgery history, except for diagnostic thoracoscopy

  • Malignant tumor history within the past 5 years, except for the following conditions:cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervixcancer in situ

  • Any active systemic diseases including uncontrolled hypertension, unstable anginapectoris, newly onset of angina pectoris within recent 3 months, congestive heartfailure (class II or plus of New York Heart Association, NYHA), myocardial infarctionwithin recent 6 months, severe disease in the need of medication such as arrhythmia,liver, renal or metabolic diseases

  • Uncontrollable infections

  • Coexisting small cell lung cancer

  • Psychiatric diseases diagnosed

  • Other circumstances which is deemed inappropriate for enrollment by the researchers

Study Design

Total Participants: 339
Study Start date:
January 01, 2016
Estimated Completion Date:
January 31, 2022

Study Description

This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?

Connect with a study center

  • Beijing Haidian Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking university people's hospital

    Beijing,
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha,
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhao,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

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